BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICAL GUIDANCE PLATFORM

    MDR report key: 2008761 · Received February 11, 2011

    Report

    Report Number
    2916710-2011-00008
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    November 22, 2010
    Report Date
    January 14, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K071360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RISK HAZARD ANALYSIS ((B)(4) 2011), VARIAN BECAME AWARE OF A SOFTWARE DEFECT IN OGP 2.6 AND 2.6.1. THERE IS A DEFECT IN THE OGP'S SOFTWARE THAT INTERPRETS DICOM IMAGE POSITION AND DEFINES HOW TO DISPLAY IMAGES ON OGP. THIS DEFECT CAUSES LAT ERROR OF 0.8MM -1MM FOR DATA SETS ARRIVING TO OGP FROM ECLIPSE AND OTHER PLANNING SYSTEMS IN THE LEFT-SIDE-FIRST ORIENTATION. ERROR IS SIGNIFICANTLY LESS (0-0.2MM LAT) FOR DATA ARRIVING IN THE RIGHT-SIDE-FIRST ORIENTATION -FROM FAST PLAN OR FROM ECLIPSE VIA FASTPLAN. THIS ISSUE IS ONLY APPLICABLE TO SITES USING DIRECT ECLIPSE OR OTHER NON FASTPLAN 3RD PARTY TREATMENT PLANNING SOFTWARE THAT SEND DATA IN TRUE DICOM FORMAT. THIS ISSUE AFFECTS BODY ARRAY, FRAMELESS ARRAY AND FRAMELESS ARRAY SRS. IN CASE OF FRAMELESS ARRAY SRS, THIS ERROR MAY EXCEED THE CLINICAL TOLERANCE OF 1 MM. A DISCREPANCY REPORT HAS BEEN GENERATED AND A DEFECT FIX WILL BE PROVIDED TO ALL OGP CUSTOMERS IN THE CURRENTLY INITIATED SP2 SERVICE TECHNICAL BULLETIN. A PRODUCT NOTIFICATION LETTER WILL BE SENT TO OGP CUSTOMERS. NO SERIOUS INJURY OCCURRED IN THIS CASE AND THE PROBABILITY OF SERIOUS INJURY IS CONSIDERED REMOTE, HOWEVER, FURTHER ACTIONS ARE ADDRESSED IN VARIAN'S CAPA PROCESS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO ADD'L F/U TO THIS MDR IS ANTICIPATED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE ISOCENTER POSITION ON A FRAMELESS STUDY OF THE ABSOLUTE PHANTOM WAS VISUALLY AWAY FROM THE CENTER OF THE TARGET. THE DICOM COORDS ON OGP MATCHED ECLIPSE. ECLIPSE ISO WAS CENTERED ON THE BALL. THE CT WAS THEN PROCESSED IN FASTPLAN AND THE NEW CT EXPORTED TO ECLIPSE. A NEW PLAN WAS CREATED WITH A FIELD ISOCENTER TO THE TARGET BALL. THIS WAS EXPORTED TO OGP. THIS TIME THE ISOCENTER POSITION WAS CENTERED ON THE BALL. IN SUMMARY, THE PROCESSED CT RESULTED IN GOOD VISUAL ALIGNMENT, BUT THE UNPROCESSED CT EXHIBITED THE VISUAL OFFSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTICAL GUIDANCE PLATFORM ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. HZ6

    Patients

    Seq Age Sex Outcome Treatment
    1